The aim of this Randomised Controlled Trial (RCT) is to test the effects of a structured physical activity (PA) program on symptoms in female outpatients aged 18 to 40 years with a diagnosis of Borderline Personality Disorder (BPD). The main questions it aims to answer are:
1. Does a structured PA program reduce clinical symptoms in patients with BPD? 2. How does the effectiveness of a structured PA program compare to a psychoeducational intervention in reducing clinical symptoms and improving physical activity parameters?
Participants will participate in a 12-week structured PA program preceded by three weekly psychoeducation sessions focused on nutrition (intervention group) or will receive a 12-week psychoeducational program on nutrition and PA (control group).
Researchers will compare the intervention group (structured PA program) and the control group (psychoeducational program) to see if the structured PA program leads to greater improvements in clinical symptoms and physical activity parameters. Moreover, the study includes a multidimensional assessment (physical, psychological, and biological) at four time points: at the start of the treatment (T0), at 6 weeks (mid-treatment, when changes from PA become visible and measurable), at the end of the 3-month treatment period (T3), and at a 3-month follow-up after the treatment (T6).
Female gender.
Age between 18 and 40 years.
Primary diagnosis of Borderline Personality Disorder (BPD) according to the diagnostic criteria of the DSM-5.
Outpatient treatment.
Current pregnancy or planning a pregnancy within the next 6 months.
Acute psychotic symptoms.
Comorbidities with Eating Disorders, Substance Use Disorder, and Bipolar Disorder.
Absolute contraindications to physical exercise, such as medical conditions that interfere with the ability to perform exercise or with the physiological response to exercise tests, e.g., the use of beta-adrenergic blocking agents.
Parallel
Structured Physical Activity Programme
BehavioralA somatic examination will also be conducted by a sports physician, which will include the assessment of muscle strength, cardiorespiratory fitness, walking gait, blood pressure, and body mass index (BMI). Based on this evaluation, the sports physician will design a personalised physical activity programme for the participants in the intervention group.
Psychoeducational Programme
BehavioralThe control group undergoes a 12-week psychoeducational programme on nutrition and PA, consisting of 8 sessions. Led by a dietitian and psychologist, topics include PA benefits, healthy eating, and sedentary lifestyle risks. The experimental group receives 3 sessions on dietary habits before starting PA intervention, ensuring differentiation. It's expected the experimental group directly benefits from exercise, while the control group benefits from PA education. At the trial's end, control group members can join the PA programme for free.
Reduction in Borderline Personality Disorder Symptomatology
The Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) scale measures borderline personality symptomatology. A reduction in score of at least 3.5 indicates improvement, as demonstrated in previous pharmacological treatment studies. Administered at baseline, end of treatment (T3), and end of follow-up (T6) to assess the impact of structured PA treatment on DBP symptomatology. Evaluators blinded to group assignment will obtain and examine outcome measurements.
Improvement of BPD-Related Symptomatology
Additional primary outcomes include psychological variables associated with BPD, including sleep hygiene, mood changes, anxiety, impulsivity, and disability impact on daily functioning. Assessment tools include the Experience Sampling Method (ESM), Beck Depression Inventory short form (BDI-13), State-Trait Anxiety Inventory (STAI-Y), Impulsive Behavior Scale (UPPS-P), World Health Organization Disability Assessment Schedule (WHODAS 2.0), and Premenstrual Symptom Screening Tool (PSST). ESM utilizes a custom app for real-time evaluation, while other tools are self-reported questionnaires administered at different time points throughout the study.
Improvement of Physical Activity-Related Parameters
The secondary outcomes aim to measure increased physical activity (PA) intensity and quantity using actigraphic, dynamometric measures, and questionnaires at various intervals. Expected physical health improvements include enhanced muscle strength, cardiorespiratory fitness, blood pressure, and BMI. Biological markers such as BDNF, kynurenine, cortisol, and DHEA, as well as specific biomarkers like agrin and Nf-L, will be analyzed post-PA intervention. Additional assessments cover innovative biomarkers, resting blood glucose, and basic hematological analyses. Motivation and self-regulation will be assessed using validated Italian versions of BREQ-3, P-scale, and RSES.
Reduction of Premenstrual Symptom Exacerbation
The presence, severity, and changes in premenstrual symptoms will be assessed using the Premenstrual Symptom Screening Tool (PSST) questionnaire.
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